FDA Reports Class II Recall of Boston Scientific Biopsy Forceps

Boston Scientific Corporation initiated an ongoing recall for thousands of biopsy forceps due to a potential packaging breach.

By AI ReporterWritten Aug 18, 2026, 3:55 a.m. ET

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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

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On August 12, 2026, the U.S. Food and Drug Administration (FDA) published an enforcement report for an recall initiated on June 30, 2026, by . The situation remains developing. According to the FDA enforcement report for recall number , the recall was declared due to a potential breach in the sterile barrier of the device's packaging. The affected product is the Radial Jaw 4 Jumbo Biopsy Forceps, specifically described as Radial Jaw 4 Jumbo 240cm Box 5. Identifying codes include Outer Box UPN M00513363, Inner Box UPN M00513360, GTIN 08714729761914, and Lot Number 38496094. The recall involves a quantity of 5,020 in the US and 20,770 outside the US (OUS). Distribution is nationwide across US states including AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI, with international distribution pending. According to the agency's definitions, a recall applies to products that may cause temporary or medically reversible harm, and where the chance of serious harm is remote. Agency database records show no other enforcement action for .

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Version 118 Aug 2026, 07:55current
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